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Laws & Regulations - Medical Devices - Provisions for Medical Device Registration
Provisions for Medical Device Registration
 
2012/3/20 14:45:46Source: Hits:

Chapter I General Provisions

Article 1 These Provisions are formulated with the view to standardizing the administration on medical device registration and ensuring safety and effectiveness of medical devices in accordance with the Regulations for the Supervision and Administration of Medical Devices.

Article 2 Medical devices to be distributed or used within the territory of the Peoples Republic of China shall be registered in accordance with the Provisions. Unregistered medical devices shall not be distributed or used.

Article 3 Medical device registration refers to the process for conducting systematic assessment, according to official procedures, on the safety and effectiveness of medical devices to be marketed and used, so as to decide whether or not to approve their marketing and use.

Article 4 The State administers a classified registration of medical devices.

A domestic Class I medical device shall be reviewed and, if approved, granted with a registration certificate by the (food and) drug regulatory authority of a municipality consisting of districts.

A domestic Class II medical device shall be reviewed, and, if approved, granted with a registration certificate by the (food and) drug regulatory authority of a province, autonomous region or municipality directly under the Central Government.

A domestic Class III medical device shall be reviewed, and, if approved, granted with a registration certificate by the State Food and Drug Administration.

An overseas medical device shall be reviewed, and, if approved, granted with a registration certificate by the State Food and Drug Administration.

Unless otherwise provided in the Provisions, the registration procedure of a medical device from Taiwan, Hong Kong, or Macao shall be referred to that of an overseas medical device registration.

A Medical Device Registration Certificate is valid for four years.

Article 5 Medical Device Registration Certificates shall be uniformly printed by the State Food and Drug Administration. The content shall be filled in by the (food and) drug regulatory authority which reviews and approves the products. The registration number is formed as the following:

()1 (Shi)Yao Jian Xie (2)Zi 3Di456Hao, in which

()1 refers to the abbreviation for the place where (food and) drug regulatory department is located:

For a domestic Class III medical device, an overseas medical device, and a medical device from Taiwan, Hong Kong, or Macao, Guo is marked;

For a domestic Class II medical device, it is the abbreviation of the province, autonomous region, or municipality directly under the Central Government, where the (food and) drug regulatory department is located;

For a domestic Class I medical device, it is the abbreviation of the province, autonomous region, or municipality directly under the Central Government, where the (food and) drug regulatory department is located, plus the abbreviation of the local municipal administrative region consisting of districts, as 1.  (Where there is no such municipal administrative region consisting of districts, it is only the abbreviation of the province, autonomous region, or municipality directly under the Central Government);

2 refers to the type of registration (Zhun, Jin, Xu):

Zhun applies to domestic medical devices;

Jin (I: Import) applies to overseas medical devices;

Xu applies to medical devices from Taiwan, Hong Kong, or Macao;

3 refers to the approval year of registration;

4 refers to the product administrative classification;

5 refers to the code of product category;

6 refers to the serial number of registration.

A Medical Device Registration Certificate is attached with a Medical Device Registration Form (see Appendix 1). The form shall be used together with the registration certificate.

Article 6 A manufacturer submits an application for medical device registration, takes relevant legal responsibilities, and is the holder of the Medical Device Registration Certificate which is granted. Persons engaged in application for the medical device registration shall be authorized by the medical device manufacturer and shall have relevant professional knowledge and be familiar with laws, regulations, provisions, and technical requirements on the administration of medical device registration.

As for registration application of an overseas medical device, an overseas manufacturer shall designate an agent located in China, which shall take relevant legal liabilities; and it shall authorize a legal person institution with relevant qualifications or its branch in China to provide after-sales service for the medical device.

Article 7 A medical device for registration shall have an applicable product standard, which can be national standard, industry standard or registration product standard established by the manufacturer. The registration product standard shall not be lower than national standard or industry standard.

Registration product standard shall be compiled in line with the administrative requirements of medical device standard specified by the State Food and Drug Administration.

Article 8 When applying for registration of a Class II or Class III medical device, the manufacturer shall meet the requirements of the State Food and Drug Administration on production conditions and related quality system.

Chapter II  Registration Testing of Medical Devices

Article 9 Registration testing of Class II and Class III medical devices shall be conducted by medical device testing institutions recognized by the State Food and Drug Administration in conjunction with the General Administration of Quality Supervision, Inspection and Quarantine. Unless confirmed to meet the applicable product standard, a medical device shall not be used for clinical trial or apply for registration.

The list of medical device testing institutions recognized by the State Food and Drug Administration in conjunction with the General Administration of Quality Supervision, Inspection and Quarantine (medical device testing institutions for short) shall be promulgated separately.

Article 10 A medical device testing institution shall test medical devices for registration in accordance with its testing scope approved by the State Food and Drug Administration and the General Administration of Quality Supervision, Inspection and Quarantine, pursuant to the applicable product standards of the medical devices, including national standards, industry standards, or registration product standards established by the manufacturer, and shall provide the test report.

A Medical device that is not yet included in the approved testing scope of current medical device testing institutions shall be tested by a qualified testing institution with relevant capacity, which is appointed by the corresponding(food

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